Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

N/AUnknownNCT00942006

University Medical Centre Ljubljana200 enrolled

Overview

The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Suspected Early Lyme Neuroborreliosis

Interventions

doxycyclineDRUG

100 mg bid, 14 days

ceftriaxoneDRUG

2g x 1 iv, 14 days

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age \>15 years * erythema migrans in 4 months period before neurologic symptoms * normal CSF cell count * absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy). Exclusion Criteria: * pregnancy * lactation * allergy on doxycycline and ceftriaxone * immune deficiency.

Locations (1)

UMC Ljubljana, Department of Infectious Diseases

Ljubljana, Slovenia

Outcomes

Primary Outcomes

Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days.

Time frame: 1 year follow-up

Central Contacts

Katarina Ogrinc, MD PhD

CONTACT

+386 1 522 4217 katarina.ogrinc1@guest.arnes.si

Franc Strle, PhD MD

CONTACT

+386 1 522 2110 franc.strle@kclj.si

Data from ClinicalTrials.gov

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